Environmental Health Tracking & Biomonitoring Program Summary: June 11, 2013 Advisory Panel Meeting Advisory Panel: Alan Bender, Fred Anderson, David DeGroote, Melanie Ferris, Tom Hawkinson, Gregory Pratt, Pat McGovern, Geary Olsen, Cathy Villas-Horns, Lisa Yost. MDH: Jeanne Ayers, Mike Convery, Deborah Durkin, Betsy Edhlund, Tannie Eshenaur, Carin Huset, Jean Johnson, James Kelly, Pat McCann, Jessica Nelson, Rita Messing, Paul Moyer, Barbara Scott Murdock, Christina Rosebush, Jeannette Sample, Ed Schneider, Blair Sevcik, Paul Swedenborg, MPCA: Frank Kohlasch MDA: Joe Zachman Others: Rebecca Wood, Mankato State University Legislative Update and Summary Assistant Commissioner Jeanne Ayers gave the update; Assistant Commissioner Aggie Leitheiser could not attend. Jeanne reviewed highlights of the 2013 legislative bills relevant to the EHTB program. These included… • • • • An appropriation of $313,000 for Fiscal Years (FY) 2014-15 to support a third round of PFC biomonitoring in the East Metro. This effort will re-test participants who had been biomonitored in two earlier biomonitoring projects and will also expand the biomonitoring efforts to collect and assay PFCs in blood samples from a wider range of East Metro residents. An appropriation of $499,000 for FY 2014-15 to support health impact assessments, biomonitoring, and community engagement to address chronic respiratory burden in high-density urban areas and mercury levels in children and newborns in Minnesota. A law that provides authority for MDH to continue collecting, storing, using, and disseminating biological specimens and health data for health department program operations, public health practice, and public health oversight activities. MDH must also develop and publish retention schedules for biological specimens and publish an annual inventory of biological specimens, registries, health data, and databases. An appropriation of $100,000 for the biennium to enable MDH to track, respond to, and prevent childhood lead exposure. After Jeanne Ayers’s review of the new legislation, Jean Johnson introduced Pat McGovern as the new Advisory Panel chair. Bruce Alexander has stepped down from the chair’s position, but is still an active member on the panel. 63 Progress and Next Steps in Newborn Mercury Biomonitoring Jean Johnson briefly reviewed the Advisory Panel’s recommendations for further mercury and PFC biomonitoring and summarized the status of current projects and planning for new projects that will take place under FY 2014-15 state funding. In earlier meetings, the panel had recommended that EHTB staff measure prenatal total mercury exposure in matched pairs of umbilical cord and heel stick blood spots for… • • Direct comparison of blood spot concentrations to the EPA reference level (based on cord blood measurement) to learn whether biomonitoring newborn blood spots is appropriate for informing public health action & for use in future biomonitoring studies; Further laboratory work to refine and publish the laboratory methods is ongoing; Planning for additional biomonitoring of newborns in other parts of the state will begin with the discussion of recruitment methods in this meeting. In this meeting, Jean said, Jessica Nelson will report preliminary results for the first comparison, the Pregnancy and Newborns Exposure Study (See next section). Two other studies have been initiated, one near the Riverside area of Minneapolis and one in southwestern MN and southeastern SD, and will use existing newborn blood spots. The panel also recommended a third round of biomonitoring of participants in earlier East Metro PFC biomonitoring and in an expanded sample of residents, including newcomers. • Because of new state funding for this project, planning for the next phase of PFC biomonitoring begins in July 2013 (See PFC Biomonitoring… below). The Pregnancy and Newborn Exposure Study Jessica Nelson presented preliminary results of the MDH EHTB collaboration with University of Minnesota investigator Dr. Ruby Nguyen, the principal investigator for the Minnesota arm of The Infant Development and Environment Study (TIDES). The MDH add-on to TIDES collected both cord blood and newborn blood spots in order to compare total mercury (Hg) levels found in paired newborn cord blood and heel stick spots. The goal was to aid in the interpretation of blood spot results from the MDH Mercury in Newborns in the Lake Superior Basin 1 pilot study. The collaborative study also analyzed the cord blood for lead and cadmium and, later in the summer, will speciate mercury in cord blood samples to ascertain the inorganic and methylmercury content. The study is also analyzing TIDES questionnaire data to learn 1 Final Report to EPA: Mercury Levels in Blood from Newborns in the Lake Superior Basin (PDF: 2637KB/181 pages) 64 whether demographics, behaviors, or other characteristics of the mother are associated with mercury, lead, and cadmium levels in the newborn. Pregnant women enrolled in TIDES during their first trimester visit to University-Fairview Riverside Hospital in Minneapolis. In the third trimester, they were recruited and enrolled in the MDH-TIDES collaboration. Of those approached, 76% consented and gave biological samples. All cord blood samples were collected by the attending physician at the birth of the babies, and the Riverside Laboratory measured the hematocrit values for the cord blood. Extra newborn blood spots were collected when newborn blood spots were taken for routine newborn screening. Cord blood and newborn blood spots were sent to the MDH Public Health Laboratory for metals analysis; in total, the study had 52 cord blood samples and 51 newborn spot samples. Of these, 48 matched cord and newborn spot pairs were available Cord blood results and letters of explanation were sent to TIDES, and the TIDES staff sent each baby’s results to its mother. Laboratory analyses detected mercury in 65% of cord blood samples, lead in 46%, and cadmium in 67%. Only one baby had cord blood mercury above 5.8 µg/L, the Environmental Protection Agency (EPA) reference level. None of the babies had lead over the 5 µg/dL CDC reference level. And all the babies had very low cadmium results. Only 16 babies had detectable mercury in both the newborn spot blood and in the matched cord blood sample. Another 32 matched pairs had detectable mercury either in the blood spot or cord blood. Overall, 61% of the newborn spot samples had no detectable mercury, compared to 35% non-detects in the cord blood. This result reflects a difference in detection limits between the two laboratory methods. In the 16 matched cord-spot samples with detectable mercury in both, cord blood mercury levels slightly exceeded newborn spot mercury levels in most cases. Jessica presented the results of two types of correlation analyses (Spearman and Pearson) for three different sub-groups: all paired cord and newborn spot samples; all paired samples in which mercury was detected either cord or newborn spot; and the 16 paired samples in which mercury was detected in both cord and newborn spot blood (Table 1). She then asked panel members for advice about which correlation would be most useful in presenting the data. 65 Table 1. Cord-spot relationship: Correlation Paired cord and NBS sample (n=48) Hg detected in cord or NBS (n=32) Hg detected in cord and NBS (n=16) Spearman 0.67 0.58 0.58 Paired cord and NBS sample (n=48) Hg detected in cord or NBS (n=32) Hg detected in cord and NBS (n=16) Pearson 0.89 0.88 0.93 r r p-value <0.0001 0.0005 0.02 p-value <0.0001 <0.0001 <0.0001 She then turned to data from the TIDES survey, including demographic data, seafood meals per week, ecofriendly food consumption, and season of birth, to look for factors that might be predictors of mercury exposure. Self-reported seafood consumption yielded the strongest association with higher cord blood mercury levels; women who reported eating seafood 2-3 times per week had geometric mean levels of 1.42µg/L compared to women who reported eating 0 meals of seafood per week. The data also suggested that graduate-level education and degrees and higher socioeconomic status were somewhat associated with somewhat higher cord blood mercury levels. Limited data made it difficult to look at differences in mercury levels by race/ethnicity and socioeconomic status, as the majority of participating mothers were white (87%), had relatively high household incomes, and were highly educated (24% had graduated from college or technical school; 49 percent had some graduate work or a graduate degree). Only three participants identified as minority ethnicity, two identified as “other,” and two were unknown. The data suggest that women with graduate level education had slightly higher cord blood mercury levels than women with a college degree or less. The next steps will include an analysis of whether hematocrit modifies the relationship between mercury levels in cord blood and newborn spots, a summary of results for the MN EPHT website, and a draft of a paper for publication. The questions she posed for the panel were the following: • • What implications do these results have for ongoing biomonitoring of newborns? What additional information is needed? Discussion Pat McGovern asked whether anyone on the panel wanted to address the question of using non-detects (levels below the method’s level of detection, or LOD) in the analysis and correlation analyses. Tom Hawkinson said that one should not use non-detection values (calculated as MDL/√2) 2 in calculating the rank correlations between paired cord 2 MDL/√2 is obtained by dividing the method detection limit (MDL) by the square root of 2. 66 blood and newborn spot samples, as doing so contaminates the analysis. Noting that using these values in the correlation analysis could reinforce a possible false relationship, Tom recommended using the third correlation analysis, which includes only the paired samples with detected data. Pat agreed. Tom added that the correlation is higher for the Pearson coefficient when we look only at the detected data. Greg Pratt said that he is uncomfortable imputing values below the level of detection. MPCA has struggled with that issue for quite a while, he noted, and now offers some methods for treating missing and non-detection values. He explained, it depends on what questions you want to answer and what conclusions you want to draw, as to what technique is best, but my first thought is to be skeptical because you are making assumptions about your data. Although it sometimes is useful to compute a value below the LOD, he prefers alternative methods. Alan agreed, saying that said you can force an artificial relationship by doing using non-detects. Alan added that, before we determine how to analyze non-detect values, we need to address the biological and logistical questions about which blood samples we want to collect in future biomonitoring projects. Do we want to use newborn blood spots or cord blood samples? Is one sample cheaper to collect? Is another more valid? If the cord blood and the newborn spots both show no detection of mercury, then it’s useful to use the non-detects. But if we want a quantitative analysis of the data, we need to use only the 16 paired samples with mercury detections in both samples. Jean agreed: for future biomonitoring, what question are we answering? Should we proceed by collecting newborn blood spots, cord blood, or both? “Why are there differences between cord and newborn spot blood?” Alan asked. Jessica said that the cord blood is sampled from the umbilical cord just after the birth, and the newborn blood spots are collected up to 24 hours later. She wondered whether, even in that short time, mercury could be excreted or sequestered. She added that the program would be receiving matched cord and newborn spot blood, and some maternal blood specimens from the South Dakota State University National Children’s Study Vanguard site in western Minnesota/eastern South Dakota. These can give more data to help answer these questions. Lisa Yost asked, isn’t the issue whether we can use newborn spots for primary screening instead of cord blood? Jean agreed that the larger question is whether using newborn blood spots is valid for population health surveillance via biomonitoring, given that sampling cord blood is more expensive. Jessica added, we want to be able to study trends [of mercury or other analytes] over time and compare exposures in population sub-groups. Greg asked about the relationship between maternal blood and cord blood. Agreeing that mercury levels vary between maternal blood and cord blood, Jessica asked the MDH Environmental Health staff for comment. Pat McCann, MDH Fish Consumption Advisory Program director, responded that mercury concentrations in maternal blood 67 can vary greatly from mercury concentrations in cord blood. The average cord:maternal blood ratio is about 1.7, but can be as high as 6.0. She also noted that looking at the hematocrit values for cord blood could help explain some of these differences. She added that Grandjean 3 had recommended that looking at hematocrit could help address that question. And, as Jessica reported earlier, that is part of the plan in this pilot study. Pat McGovern said that she is working with a neonatologist in Pediatrics at the UMN who studies iron deficiency in newborns and might be able to provide some insights on these questions. Turning attention to the second question, Pat McGovern asked whether staff might do any GIS (Geographic Information Systems) investigations on geographic location of the mothers’ neighborhoods, as that might be relevant and interesting—especially as we add more numbers through other projects. Jeanne Ayers commented on the use of the word, “seafood,” in the survey questions, rather than the word “fish.” Pat McCann said that, in Minnesota, people don’t think of seafood as fish. Jessica agreed that this wording is a limitation in the way the larger TIDES projects asked the question in the survey. Tom said that many people don’t see canned tuna as either fish or seafood. And Greg urged staff to ask about all three categories—fish, tuna, and seafood—in future surveys. Finally, Alan Bender encouraged staff to publish these findings in the peer-reviewed literature. He acknowledged that staff aren’t given time to do this, and that they needed to write papers on their own time. But, he stressed, it’s imperative that these results get into the literature. Recruitment & Consent for Pregnant Women and their Newborns Recruiting and obtaining consent to study pregnant women and their newborns poses challenges that range from identifying women in their early months of pregnancy to ensuring that participants in the study represent the diversity of the larger population. These presentations report experiences from three different activities: the EHTB pilot projects, The Infant Development and Exposure Study (TIDES), and the National Children’s Study (NCS). • • Jean Johnson briefly reviewed methods used for recruitment and consent in three EHTB pilot projects, along with the participation rates obtained with each method. Pat McGovern compared and contrasted several methods used in the NCS to identify, recruit, and obtain consent from pregnant women using a probabilitybased sampling approach and discussed the strengths and shortcomings of each. 3 Philippe Grandjean, University of Southern Denmark, an expert on health risks from prenatal exposure to methylmercury. 68 • Ruby Nguyen was scheduled to review the methods used for clinic-based recruitment and consent in the TIDES project, both in Minneapolis and in sister TIDES studies elsewhere in the US. She was to review the protocol from out of state, and EHTB staff were unable to make the telephone contact work. This protocol will be presented in the next Advisory Panel meeting on October 8, 2013. EHTB Pilot Project Recruitment & Consent of Pregnant Women, Newborns, & Children Jean reviewed recruitment and consent methods and the participation rates obtained for each of three EHTB pilot projects. Each pilot used a different approach to recruiting and obtaining consent from the participating women. Participation rates ranged from 44-65% of those who were identified, invited, and who subsequently gave consent. These pilots were highly effective in providing lessons for the best recruitment and consent methods for larger studies. The Minneapolis Children’s Arsenic Study used household-based recruitment of families with children age 3-10 over a three-month period. The recruitment goal was to obtain urine specimens from 100 children. The study targeted homes with known soil arsenic concentrations above a background level. The approach was door-to-door with advanced mailings in English and Spanish. Somali or Spanish speaking recruiters visited homes as needed. The project offered gift cards to local stores as incentives. Despite identifying and attempting to contact 883 households, staff were able to recruit only 40 children from 47 households. Expanded recruitment through invitations to participate mailed to 2652 households in the study area enabled staff to recruit 25 additional children. From all households that responded, staff identified 119 eligible children, but only 65 consented and provided urine samples. Overall, Jean said, the approach was costly in staff time and not likely to be cost-effective for larger studies. The Riverside Birth Cohort Study of Pregnant Women used mail and clinic-based recruitment of pregnant women already enrolled in a birth cohort study. The goal was to recruit 100 women (including 30 Hispanic and 30 non-Hispanic black) for urine sample collection and testing for bisphenol A and four parabens. Gift cards were offered as incentives. Of 122 women contacted, 79 (65%) consented, and 66 provided a urine specimen. Very few Hispanic women visited the clinic. Special efforts to recruit Somali women with translated materials were unsuccessful. Only 4 Hispanic and 8 African American women participated. 69 The Lake Superior Mercury in Newborns Study 4 selected recent newborns from the newborn screening database. So as not to stress the parents, MDH excluded about 10% of newborns because of pregnancy complications, the infant's death, or health problems. Another 25% of potential participants were excluded because of poor quality or insufficient blood in the heel-stick blood spots. Staff then recruited newborns by mailing a letter explaining the study, a consent form, and a brochure about safe fish consumption to new mothers after they gave birth. Of all the Minnesota mothers contacted, 1,130 (44%) returned the consent forms and agreed to participate. Recruitment & Enrollment of Pregnant Women: The National Children’s Study Vanguard Study Patricia McGovern reviewed the four strategies for recruiting women into a pregnancy cohort that were tested in the National Children’s Study. All used a probability-based sampling approach, including: • • • • Household-based (Original Vanguard Study, or OVS) Enhanced Household-based Recruitment (EHBR) Provider-based Recruitment (PBR) Direct Outreach (i.e., High-Low Intensity). The OVS used a household-based approach with broad community engagement to create awareness of the study, followed by mailings to all households in randomly selected neighborhoods. The mailing informed households of the study and alerted families when study staff would be in their neighborhoods. Study staff went door to door to identify households with age-eligible women, interview them for study eligibility, and invited those eligible to participate in the study. Results from 18 months of recruitment in 7 study centers found that only 10% (N= 3,100) of the 30,900 women screened met the criteria of being pregnant or trying to conceive; 63% (N=1950) of these eligible women consented to participate. These results led the National Children’s Study Program Office to contract with 30 additional Study Centers to test three alternative recruitment strategies. The EHBR Strategy hired study staff from the neighborhoods where the potential participants lived, intensified advertising, media (radio and television ads); and used more community engagement practices. Over a shorter recruitment period (14 months vs. 18 months), this strategy slightly increased identification of eligible women 4 The “Mercury in Newborns in the Lake Superior Basin” study was conducted by the MDH Environmental Health Division from 2007 to 2011, in collaboration with state newborn screening programs in Minnesota, Wisconsin, and Michigan. It was primarily funded by the U.S. Environmental Protection Agency (EPA), with additional funding provided by the MDH Division of Environmental Health and the MDH Environmental Health Tracking and Biomonitoring Program. 70 (pregnant or trying to conceive) from screening to 13% (from 10% in the OVC) and enrolled 63% of eligible women, comparable to enrollment percentages in the OVC. The PBR Strategy identified prenatal care providers in a specific county to identify women who lived in randomly selected neighborhoods and then recruited women from those providers using mailings and follow-up calls. Using the same 14 month recruitment duration as the EHBR approach, this method greatly increased identification of eligible women (pregnant or trying to conceive) from screening to 76% (vs. 10% from OVS and 13% in EHBR), and enrolled higher percentages of eligible women with consents at 76% (vs. 63% in the OVC and EHBR). The Direct Outreach approach used broad community outreach county-wide, plus intense outreach in randomly selected neighborhoods to create awareness of the study. Then household mailings were sent to all listed addresses in the selected neighborhoods to invite residents to call the study center if there were age-eligible women in the household to see if any that were study eligible. During 11 months of recruitment, this method identified 18% of eligible women (pregnant or trying to conceive) from screening (vs. 10% from OVS, 13% from EHBR, 76% from PBR), and enrolled 80% of eligible women (vs. 63% in the OVC and EHBR, 75% from PBR). The Direct Outreach approach reported the highest proportions of women who spoke English, had college degrees, were married, and were 25 years or older. This outcome is associated with a recruitment strategy that requires women to take the initiative to contact study staff for eligibility screening. The provider-based sampling was the most efficient of all of the recruitment methods tested. It led to: • The highest yield of pregnant women • The lowest yield of preconception women • The highest rate of enrollment for pregnant women • One of two highest rates for enrollment of preconception women. The accompanying biases for the provider-based sampling were the following: • • • Slightly more non-Hispanic blacks, slightly fewer Hispanics compared to countylevel population data Slightly more women of 25-34 years and < 24 years compared to county-level data, and relatively fewer women 35 years of age and older compared to county level data. Proportion of married women and partnered women almost comparable to county-level data. Pat then briefly described a multi-stage probability sampled birth cohort that would use the provider-based recruitment strategy. The approach would create a geographic frame and probabilistically select areas with about equal numbers of births and sample 71 systematically from hospitals, birth centers, and other prenatal providers. The method would also target underrepresented women of scientific interest. Discussion Jean Johnson asked the panel, what are the takeaway messages for biomonitoring? • • • • What can MDH-EHTB learn from the NCS and TIDES study protocols that will guide future protocol decisions in MN? Can a clinic-based protocol address issues of participation bias for surveillance purposes? Are results likely to be generalizable? Are minorities likely to be represented? Alan commented that, to control biases, in the transition from research to the identification of problems that need to be detected on a population basic, data must be reportable without consent. None of these strategies for recruiting pregnant women will give an unbiased result as mandatory reporting does for public health surveillance. Opting into or out of reporting introduces bias into studies. If we know that it’s important to identify mercury in newborns statewide, for example, the exposure ought to be a reportable condition. Routinely collected data should be available to study, as cancer or food poisoning data are, he argued; look at the efforts involved in recruitment of participants for studies. Noting that research studies always require informed consent, Pat McGovern commented that taking baby steps might be useful before making an all-or-nothing decision about this. It would be an enormous request to ask for mandatory reporting. Fred Anderson said that there are other ways to study portions of the population, such as settlement houses or local communities, but each has its drawbacks— socioeconomics, or geographic areas—so all studies have biases. Alan said we should not make new requests, but use existing data reporting systems; if heel sticks are collected on every baby, we should be able to use those spots to identify problems in the population. Jean added, under current law, I do not see how we will ever get to use existing specimens without consent. We will always have bias in recruitment for studies; given the privacy laws we have today, we always expect to have to obtain consent for biomonitoring; and we will always have to manage and explain bias. Pat McGovern pointed out that the provider-based model seems to be very effective in recruiting women for studies. And Melanie Ferris suggested that, to prevent bias toward higher socioeconomic study participants, studies of pregnant women and their babies could also work with such agencies as WIC clinics and community-based clinics to reach more diverse, underrepresented women. Pat McCann, MDH Fish Consumption Advisory Program director, asked about the participation rates for requests to use newborn blood spots in Logan Spector’s Riverside 72 study and the National Children’s Study. Neither Pat McGovern nor Jessica Nelson knew those rates off the cuff, but Pat McGovern estimated that the NCS rates were about 67%. Pat McCann replied that, according to Alan, the participation rates used to be around 80%. What has changed? What do we expect now? Lisa wondered how other states deal with the problem, but added that, overall, the population has changed—it is now less homogeneous, and people may not trust their institutions as much. For each community one needs to work with insiders, but how well that works can vary. Pat McGovern pointed out that the provider-based approach they used led to a 78% recruitment rate—close to the earlier 80% rate. Jean added that studies can use the approach used in the NCS—comparing data from recruited participants with the census data, to identify whether and where there are biases. Biomonitoring updates Jean Johnson expanded on two of the updates. The first was the Biomonitoring Summit. This one-day event convenes leaders in state biomonitoring and Minnesota stakeholders to share accomplishments from Minnesota’s biomonitoring program, to learn about biomonitoring programs in key states, and to develop an expanded vision for biomonitoring’s future in public health improvement in Minnesota. As of June 11, the day of the Advisory Panel meeting, staff had recruited speakers from Wisconsin, California, and Washington State to discuss their state biomonitoring programs, and over 60 people had registered for the conference. She also gave a brief update on the East Metro PFC Biomonitoring Follow up Project Community meeting held in May to discuss the project’s findings with participants, community members, local public health officials, legislators, and other key stakeholders. About 40 people—community members and stakeholders—listened to the presentations and took part in discussions during and after the event. The next steps are to discuss the results of the project with local health providers and to complete an update of cancer rates in Washington and Dakota Counties and to make the analyzed information available to residents of those counties. No other updates were discussed. PFC Biomonitoring Goals for an Expanded Sample (PFC3) Jessica set the stage for the discussion of how to set the goals of the next East Metro PFC project. As recommended by the Advisory Panel, she said, the final FY 2014-15 Minnesota State budget includes two years of funding for a third round of PFC biomonitoring in the East Metro. This follow-up project has two components: 1) Re-contacting participants in the two earlier biomonitoring projects for consent to collect a third blood sample (164 people took part in the 2010 project). 73 2) Expanding the sample to include about 200 additional people from the East Metro who are not necessarily long-time residents (long-term residence was one criterion for the earlier biomonitoring projects). To plan this next round of PFC biomonitoring, Jessica requested Advisory Panel advice and suggestions on the goals for measuring PFCs in the expanded sample of participants (group #2, above). She listed a few possibilities for discussion: • Assess exposures in a representative sample of East Metro residents, including both long-time and newer residents. • Assess exposures in newer residents of these communities, i.e., people who moved to Oakdale, Lake Elmo, or Cottage Grove after Jan. 1, 2005, when remediation measures began to reduce PFC levels in drinking water. • Respond to legislative interest in measuring PFC exposures in children and in certain potentially vulnerable groups (including farmers in the area). • Some combination of the above. To address the question of biomonitoring children for PFCs, Christina Rosebush reviewed what is known about children’s PFC exposures, measured as serum concentrations of PFCs. She used data from published biomonitoring studies (Olsen 2004,5 NHANES,6 Emmett et al.7, ) that measured PFCs in children. In the Olsen study of 598 children in a multicenter trial, the youngest children, because of their hand-tomouth behavior, had higher 95th percentile estimates for PFHxS and M570 (a precursor to PFOS) than adults. In children aged 2 years to 12 years, PFOA and M570 levels were higher in the youngest children in that range than in the oldest. In the NHANES study, which had pooled serum data from 2001 and 2002 for children, adolescents, and adults, mean concentrations of PFCs in the young children’s pools were higher than in adolescents and adults. Studies of PFOA exposure in the C8 Study in West Virginia and Ohio found that residents over 60 years of age had significantly higher serum PFOA levels compared to all other age groups except children aged 2 to 5 years old. This may be because these age groups are more likely to be at home and drinking water at the home. Jim Kelly discussed the question of biomonitoring local East Metro farmers, including the Hmong truck farmers who supply the Farmers’ Markets. The public concern expressed was that PFCs in area landfills might have contaminated irrigation waters for crops or that PFCs could have volatilized from a spray system used to remove volatile organic compounds from a particular contaminated landfill. MDH’s Environmental Health (EH) Division staff concluded that the older types of PFCs in that landfill are not 5 6 7 Olsen, G.W.; Church, T.R.; Hansen, K.J.; Burris, J.M.; Butenhoff, J.K.; Mandel, J.H.; Zobel, L.R. Quantitative Evaluation of Perfluorooctanesulfonate (PFOS) & Other Fluorochemicals in the Serum of Children. Jour. Children’s Health. 2004, 2(1), 53-76. Kayoko Kato; Lee-Yang Wong; Lily T. Jia; Zsuzsanna Kuklenyik; Antonia M. Calafat; Environ. Sci. Technol. 2011, 45, 8037-8045 Emmett EA, et al., Community exposure to perfluorooctanoate: relationships between serum concentrations and exposure sources. J Occup Environ Med. 2006 Aug;48(8):759-70 74 volatile, so were unlikely to contaminate nearby crops. Because residents had gardened for many decades in the area, EH staff performed the PFCs in Homes & Gardens Study near the disposal sites where crops had been irrigated with contaminated water. The study found that soil levels were well below residential soil reference values established by the Minnesota Pollution Control Agency; only low levels of PFCs were found in the produce that was tested. 8 Other farm fields are irrigated with well water that is not contaminated, so MDH staff concluded that neither current farmers nor their crops are being exposed to PFCs at levels of concern. Fred asked whether Jim was talking about truck farmers, such as Hmong farmers. Jim said, yes. Discussion Jessica asked the panel to consider the questions posed in the background book: • • Do panel members have a recommendation about the goal of the expanded sample? Should children or other special groups be targeted? In addressing the goal, Alan began by asking how children had been studied in other projects, specifically Geary Olsen’s study of PFCs in children. Observing that the Olsen study had used existing samples of children’s blood for the PFC study, he said that MDH doesn’t support taking blood samples from infants, unless doing so offers an important benefit to the child. Geary said that the two chemicals tested (PFHxS and M570) were used in Scotchguard-like applications to carpeting. His study found that very young children’s higher exposures reflected their behavior patterns, such as hand-to-mouth activity and playing on the floor. Older children had less exposure. NHANES subsequently also reported this pattern of exposure. Given 3M’s phase-out of PFOS, it is uncertain whether this pattern of exposure to PFCs in carpet continues. The East Metro exposure concern is different, he said, it’s water-based exposure. MDH’s PFC exposure studies focused on drinking water exposure because the likely source was water. The question about adding children asks, is there something different in children that we want to understand that is based on water exposure? Fred pointed out that the children of new residents have all been exposed to East Metro water since 2005. And because mitigation of PFCs in drinking water began in 2005, most East Metro children should not have high PFC levels from the water. Lisa commented, it really would not make sense to biomonitor children, since the likelihood of current exposure is very low, now that the water contamination has been reduced. This implies 8 Perfluorochemicals (PFCs) in Homes and Gardens Study. Status report in December 2012 Advisory Panel book, MDH EHTB program, December 2012. http://www.health.state.mn.us/divs/hpcd/tracking/panel/2012decmaterials.pdf 75 that newer residents—those who moved in after treatments to reduce PFCs in the water began—should have low PFC levels that are similar to those in the general population. For clarification, Greg Pratt asked, was the intent of the legislation aimed at learning about the water-PFC exposure or was it intended to identify all sources of exposure? Geary said, the panel’s recommendation to biomonitor new residents was made to capture people exposed only to the recent—mitigated—PFC water levels. Jessica concurred. The driving reason is to make sure the blood levels are still coming down in the older population and that the new population should not have very elevated levels, more than the general population. Jean said that, in testimony at the legislature, she had explained the Advisory Panel’s recommendation to expand the population sample in the East Metro. 9 The purpose of the third round of East Metro PFC biomonitoring is to assure legislators and East Metro residents that PFC levels in older residents are still declining and that newer residents— those who moved into the East Metro after treatments to reduce PFCs in the water began—are likely to have PFC levels that look like those in the general population. The goal is to assure residents that this history of [drinking water contamination] caused PFC exposures in the residents and that the measures taken to reduce PFCs in the water have worked. Because some legislators then asked whether we were planning to test children and Hmong farmers, we want to make sure the panel still agrees with the original goal. Melanie raised another reason to focus only on adult East Metro residents. The budget for the extended sampling would only allow about 200 participants. Does this study population have room to include children or other groups? If the population sample is diluted by groups other than adult East Metro residents, the study won’t be large enough to provide the assurance that the third round of biomonitoring in expanded samples of the population is supposed to address. Tom and Alan agreed that the program would dilute the sample if it included other groups. And, Fred Anderson added, for the Washington County Local Public Health Department, the goal is assurance. 9 In September 2012, the EHTB Advisory Panel recommended that MDH should pursue continuing PFC monitoring in the same participants and should expand the sample in the East Metro area so that a full range of current adults, including newcomers, are represented. Because the efforts to reduce PFCs in drinking water began in 2006, younger residents, and especially newcomers, are likely to have PFC levels that are more like the background levels seen in national surveys. Continued biomonitoring in the community would provide further assurance that the actions still being taken to protect public health are successful. Minnesota Environmental Health Tracking & Biomonitoring Report to the Legislature, p. 25. January 2013. http://www.health.state.mn.us/divs/hpcd/tracking/pubs/ehtblegreport2013.pdf 76 Pat McGovern summarized the discussion, saying, it seems that the Advisory Panel members want to stay with the original intent. Panel members agreed. To address legislators’ interest in other groups, Melanie suggested that staff summarize the literature on what is known about this group of farmers and about children’s exposure to PFCs and then, in the report on this study, explain why MDH did not include them. Finally, Jessica asked the panel to consider the sampling frame: Should we sample new residents separately or take a representative sample of all adults that could be stratified later to look at newer residents and older residents independently? David DeGroote said that two hypotheses (declining PFCs in old residents and limited PFC exposure in new residents) require two samples of the population. What’s happening in new residents requires a sample of new residents, while following up on an existing cohort requires another round of sampling. Geary asked, are you planning on sampling in parallel or almost sequentially? Recruiting 200 new participants will take some time, whereas you can re-sample the old cohort (164 participants) anytime. Jean asked whether seasonality is important, as well as population. Jean said she heard a consensus to focus only on adults and on a mix of newer and older residents. All agreed. Geary then suggested that staff might recruit more long-term residents into the new sample and frequency-match them to the existing population to make comparing their PFC levels to the original studies more interpretable. New Tracking Content: Arsenic in Private Wells Background The MDH Well Management Section and the MN Tracking Program have been collaborating to develop and pilot new tracking content for arsenic in private wells. The work included participation in the CDC Tracking Program Private Well Taskforce, which had members from several states and CDC. In March 2013, the Taskforce published a new guidance for states interested in developing measures for arsenic in private wells. Taskforce members identified arsenic as a top priority and listed several other chemicals of interest (nitrate, pesticides, VOCs). The Taskforce also published a white paper with information and recommendations for states that want to add private well questions to their module of the Behavioral Risk Factor Surveillance Survey (BRFSS). BRFSS is a cross-sectional telephone survey conducted by state health departments with technical and methodological assistance provided by the CDC. States can add questions to the survey for a fee. MDH has successfully added environmental health questions about private wells (testing), radon (testing), and carbon monoxide alarms to BRFSS in the past, but these questions have not been repeated in recent years. 77 Presentation Ed Schneider, a hydrologist in MDH’s Environmental Health division, presented findings from the MN Tracking program’s Evaluation Template and displayed a series of pilot maps of selected data on arsenic in private wells, dating from mid-2008 through January of 2013. (Please see the June 2013 Advisory Panel background book to see the Summary of Evaluation Criteria for a New State-Specific Tracking Content Area.) Since 2008, Minnesota Administrative Rules require that new wells be tested for arsenic, with results reported to MDH. One million residents of Minnesota—20% of the population—rely on private wells for their drink water. Moreover, Ed explained, although MDH recommends that all well water should be tested, no enforceable standard for arsenic in private wells applies in Minnesota, aside from the 2008 requirement that new wells be tested. An estimated 500,000 wells were constructed before 2008, and many of them have never been tested for arsenic. A 1994 CDC study of a representative sample of private wells in Minnesota calculated that 14.7% of private wells contain arsenic above 10 µg/L of water, the maximum contaminant level (MCL). Arsenic is common in Minnesota groundwater, but is more likely to be found in areas that were glaciated in the past. The largest and most recent of these is the Des Moines Lobe (Figure 1). 10 Glacial till deposited by the Des Moines Lobe contains fine silts and clays with arsenic adsorbed to the exterior of the sediment grains. 11 In places, the till also has geochemical conditions favorable to release of the adsorbed arsenic into groundwater. Arsenic that is part of the mineral matrix in the Des Moines Lobe till and in other soils, is much less likely to be mobilized. Figure 1. MDH recommends that Minnesota residents with private wells should have the water tested for arsenic and should make sure that the arsenic levels are < 10 µg/L. MDH Well Management notifies all well owners with reported arsenic >2 µg/L. Ed said that arsenic is highly soluble, tasteless, and odorless. It is fatal at doses of 60 mg or more, 10 Krippner, Mark. The Glacial Landscape of Minnesota. Quaternary Geology ES 767. November 2011. http://academic.emporia.edu/aberjame/student/krippner1/minngeo9.htm 11 Erickson and Barnes. 2004. Arsenic in Groundwater: Recent Research and Implications for Minnesota. CURA Reporter 34 (2): 1-7. Center for Urban & Regional Affairs, University of Minnesota. 78 but that arsenic levels above the MCL of 10 µg/L in drinking water can contribute to chronic diseases. People who have drunk well water containing greater than 10 µg/L of arsenic for many years have a greater risk of lung and bladder cancers than the general population. Some evidence suggests that arsenic concentrations as low as 3 µg/L in drinking may also contribute to chronic illnesses. Ed next listed the public health actions that well owners could take to protect themselves: 1) Have the well water tested 2) Use a good filtration device to remove the arsenic 3) Connect to a safe water supply, such as a community water supply that is tested and treated to reduce arsenic and other contaminants. He walked panel members through several of the maps, from those that showed the number of new wells in each county or township and the percentage of the wells that contained arsenic above 10 µg/L, to maps of individual wells sampled in Minnesota or in the Des Moines Lobe region (Minnesota, Iowa, and North and South Dakota) with arsenic concentrations > 10 µg/L and < 10 µg/L. For more, please see the Advisory Panel book for June 2013. Chuck Stroebel then presented draft BRFSS questions about private wells. The questions asked whether the respondent had a private well, whether it had been tested for arsenic and nitrate, and when. Questions posed to the panel were… • Do panel members have suggestions for improving the display and interpretation of private wells data? • What audiences or partners might be interested in using these data? How? • How might the collection of BRFSS data add value to the piloted measures (to inform public health action)? Discussion Geary asked about the costs of remediation for wells with arsenic contamination. Ed described the costs of several effective treatments: reverse osmosis units under the sink, about $1000; treatments that use absorptive media, such as iron oxide minerals, cost about $100$300. Pat McGovern asked about maintenance costs, and Mike Convery, a hydrologist supervisor in the Environmental Health Division, replied that filters must be replaced periodically, and the frequency of replacement varies by the filter. Greg suggested that the group consider some other ways to analyze the data, such as using kernel density surface smoothing for maps or correlating the data with digital maps of soil and bedrock geology. He also asked about the effects of well depth. Ed 79 replied that well depth is probably relevant, but that no correlation has been observed between the depth of a well and its arsenic concentration. Arsenic levels are often higher in a well that draws water from the top of a confined aquifer, just below a clay confining layer. Water drawn from an unconfined aquifer, above the clay layer or from deeper in the aquifer and farther below the clay layer, tends to have lower arsenic levels. So it’s hard to predict how depth will affect the arsenic level in well water. Mike added that arsenic levels are very sensitive to the particular environment where a well is constructed; two wells that are close together may contain water with completely different arsenic concentrations. Melanie asked about the audiences the well program was trying to reach; are you trying to persuade residents with older wells to re-test the water? Fred said that realtors, well drillers, homeowners, and water filtration companies would all be relevant audiences. Lisa asked about the range of typical arsenic concentrations in wells and whether or how the levels vary over time. Ed said that a few wells have been found to have levels around 200 µg/L, but that 100 µg/L is the usual worst case end of the range. Mike added that, although he isn’t sure, he doesn’t expect major variations in arsenic levels. He also said that the program had received extra funding for follow-up testing, since most testing of new wells happens right after the wells have been drilled, so the tests don’t reveal the long-term picture. Cathy suggested that the well program might consider hosting testing clinics, so people can bring in water samples and get arsenic testing results on the spot. The testing clinics could be like those held by the Minnesota Department of Agriculture to test for nitrate in private wells. The discussion then moved to considering the maps. Melanie suggested that the staff should be very thoughtful about titles, and suggested that the maps include the number of wells that exceed the 10 µg/L maximum contaminant level (MCL), not just the number of wells tested. Pat McGovern suggested that staff convene a users’ group of local public health staff to test the maps and provide map-messaging feedback. Pat also addressed the BRFSS questions, asking whether it would be possible to ask questions about more metals in the water, not just arsenic. She suggested using the CDC Task Force’s (?) list of the top 10 contaminants in water to identify the metals of interest. [Note: the list includes manganese (Mn), radionuclides (of uranium or radon, for example), nitrate (NO3), volatile organic compounds (VOCs), bacteria, pesticides, and perchlorate.] Chuck replied that BRFSS is already a long survey, so staff have to be cautious in adding more questions. Despite this, staff are considering posing questions about Rn testing and CO alarms. 80 David DeGroote asked whether staff knew where the untested wells are located in Minnesota. Is there any relationship between where those wells are and geographic areas of high arsenic concentrations? Is it possible to set priorities for testing in areas where the risk of arsenic contamination is higher? These high arsenic areas in Minnesota would be where you’d want to start testing. Ed replied that the number of untested wells is way above 100,000 and, although the well management program has a database of untested wells, he was not sure that the database has a record of their locations. Staff are considering targeting areas of high arsenic concentrations for additional testing of existing wells. Tracking updates Panel members had no questions or comments on the tracking updates. New business Panel members did not propose any new business to discuss. Audience questions Pat asked whether anyone in the audience had questions, but time being tight, received none. Motion to adjourn Pat invited a motion to adjourn, and received both a motion and a seconding of the motion. The meeting then adjourned. The next Advisory Panel meeting will be held on Tuesday, October 8, from 1:00 to 4:00 in the afternoon at the American Lung Association-Minnesota, courtesy of Jill Heins Nesvold. 81 This page intentionally left blank. 82 Environmental Health Tracking & Biomonitoring Advisory Panel Roster As of October 2013 Bruce Alexander, PhD University of Minnesota School of Public Health Environmental Health Sciences Division MMC 807 Mayo 420 Delaware Street SE Minneapolis, Minnesota 55455 612-625-7934 [email protected] At-large representative Fred Anderson, MPH Washington County Department of Public Health and Environment 14949 62nd St N Stillwater MN 55082 651-430-6655 [email protected] At-large representative Alan Bender, DVM, PhD Minnesota Department of Health Health Promotion and Chronic Disease Division 85 East 7th Place PO Box 64882 Saint Paul, MN 55164-0882 651-201-5882 [email protected] MDH appointee David DeGroote, PhD St. Cloud State University 740 4th Street South St. Cloud, MN 56301 320-308-2192 [email protected] Minnesota House of Representatives appointee Melanie Ferris Wilder Foundation 451 Lexington Parkway N St. Paul, MN 55104 651-280-2660 [email protected] Nongovernmental organization representative Thomas Hawkinson, MS, CIH, CSP Toro Company 8111 Lyndale Avenue S Bloomington, MN 55420 [email protected] 952-887-8080 Statewide business org representative Jill Heins Nesvold, MS American Lung Association of Minnesota 490 Concordia Avenue St. Paul, Minnesota 55103 651-223-9578 [email protected] Nongovernmental organization representative 83 Patricia McGovern, PhD, MPH University of Minnesota School of Public Health Environmental Health Sciences Division MMC Mayo 807 420 Delaware St SE Minneapolis MN 55455 612-625-7429 [email protected] University of Minnesota representative Geary Olsen, DVM, PhD 3M Medical Department Corporate Occupational Medicine MS 220-6W-08 St. Paul, Minnesota 55144-1000 651-737-8569 [email protected] Statewide business organization representative Gregory Pratt, PhD Minnesota Pollution Control Agency Environmental Analysis and Outcomes Division 520 Lafayette Road St. Paul, MN 55155-4194 651-757-2655 [email protected] MPCA appointee Cathy Villas-Horns, MS, PG Minnesota Department of Agriculture Pesticide and Fertilizer Management Division 625 Robert Street North St. Paul, Minnesota 55155-2538 651-201-6291 [email protected] MDA appointee Lisa Yost, MPH, DABT ENVIRON International Corporation 333 West Wacker Drive, Suite 2700 Chicago, IL 60606 Local office 886 Osceola Avenue St. Paul, Minnesota 55105 Phone: 651-225-1592 Cell: 651-470-9284 [email protected] At-large representative Vacant Minnesota Senate appointee 84 Biographical sketches of advisory panel members Bruce H. Alexander is a Professor in the Division of Environmental Health Sciences at the University of Minnesota’s School of Public Health. Dr. Alexander is an environmental and occupational epidemiologist with expertise in cancer, reproductive health, respiratory disease, injury, exposure assessment, and use of biological markers in public health applications. Fred Anderson is an epidemiologist at the Washington County Department of Public Health and Environment and has over 30 years of public health experience. .He holds a Master of Public Health (MPH) in environmental and infectious disease epidemiology from the University of Minnesota and is a registered environmental health specialist. For over 20 years, he has led county-wide disease surveillance and intervention programs, including numerous multidisciplinary epidemiologic investigations. Alan Bender is the Section Chief of Chronic Disease and Environmental Epidemiology at the Minnesota Department of Health. He holds a Doctor of Veterinary Medicine degree from the University of Minnesota and a PhD in Epidemiology from Ohio State University. His work has focused on developing statewide surveillance systems, including cancer and occupational health, and exploring the links between occupational and environmental exposures and chronic disease and mortality. David DeGroote is Dean of the College of Science and Engineering and Professor of Biological Sciences at St. Cloud State University. He has been at St. Cloud State University since 1985, initially as an Assistant Professor in Biological Sciences. He served as Department Chair from 1996 to 2003 before moving to the Dean’s Office. Most recently he had focused on providing up-to-date academic programming and facilities that serve the needs of Minnesota employers in the health sciences, engineering, computing, biosciences, and STEM education. Melanie Ferris is a Research Scientist at Wilder Research, a nonprofit research organization based in St. Paul, Minnesota. She conducts a variety of program evaluation and applied research projects focused primarily on public health and mental health. She has worked on a number of recent projects that focus on identifying disparities across populations and using existing data sources to develop meaningful indicators of health and wellness. Examples of these projects include a study of health inequities in the Twin Cities region related to income, race, and place, development of a dashboard of mental health and wellness indicators for youth living in Hennepin County, and work on local community health needs assessments. She has a Master’s of Public Health degree in Community Health Education from the University of Minnesota’s School of Public Health. 85 Tom Hawkinson is the Corporate Environmental, Health, and Safety Manager for the Toro Company in Bloomington, MN. He completed his MS in Public Health at the University of Minnesota, with a specialization in industrial hygiene. He is certified in the comprehensive practice of industrial hygiene and a certified safety professional. He has worked in EHS management at a number of Twin Cities based companies, conducting industrial hygiene investigations of workplace contaminants and done environmental investigations of subsurface contamination both in the United States and Europe. He has taught statistics and mathematics at both graduate and undergraduate levels as an adjunct, and is on the faculty at the Midwest Center for Occupational Health and Safety A NIOSH-Sponsored Education and Research Center School of Public Health, University of Minnesota. Jill Heins Nesvold serves as the Director of the Respiratory Health Division for the American Lung Association in Iowa, Minnesota, North Dakota, and South Dakota. Her responsibilities include program oversight and evaluation related to asthma, chronic obstructive lung disease (COPD), lung cancer, and influenza. Jill holds a master’s degree in health management and a short-course master’s of business administration. Jill has published extensively in a variety of public health areas. Pat McGovern is a Professor in the Division of Environmental Health Sciences at the University of Minnesota’s School of Public Health. Dr. McGovern is a health services researcher and nurse with expertise in environmental and occupational health policy and health outcomes research. She serves as the Principal Investigator for the National Children’s Study (NCS) Center serving Ramsey County, one of 105 study locations nationwide. The NCS is the largest, long-term study of children’s health and development in the US and the assessment of environmental exposures will include data collection from surveys, biological specimens and environmental samples. Geary Olsen is a corporate scientist in the Medical Department of the 3M Company. He obtained a Doctor of Veterinary Medicine (DVM) degree from the University of Illinois and a Master of Public Health (MPH) in veterinary public health and PhD in epidemiology from the University of Minnesota. For 27 years he has been engaged in a variety of occupational and environmental epidemiology research studies while employed at Dow Chemical and, since 1995, at 3M. His primary research activities at 3M have involved the epidemiology, biomonitoring (occupational and general population), and pharmacokinetics of perfluorochemicals. Greg Pratt is a research scientist at the Minnesota Pollution Control Agency. He holds a Ph.D. from the University of Minnesota in Plant Physiology where he worked on the effects of air pollution on vegetation. Since 1984 he has worked for the MPCA on a wide variety of issues including acid deposition, stratospheric ozone depletion, climate change, atmospheric fate and dispersion of air pollution, monitoring and occurrence of air pollution, statewide modeling of air pollution risks, and personal exposure to air pollution. He is presently cooperating with the Minnesota Department of Health on a 86 research project on the Development of Environmental Health Outcome Indicators: Air Quality Improvements and Community Health Impacts. Cathy Villas Horns is the Hydrologist Supervisor of the Incident Response Unit (IRU) within the Pesticide and Fertilizer Management Unit of the Minnesota Department of Agriculture. Cathy holds a Master of Science in Geology from the University of Delaware and a Bachelor of Science in Geology from Carleton College and is a licensed Professional Geologist in MN. The IRU oversees or conducts the investigation and cleanup of point source releases of agricultural chemicals (fertilizers and pesticides including herbicides, insecticides, fungicides, etc. as well as wood treatment chemicals) through several different programs. Cathy has worked on complex sites with Minnesota Department of Health and MPCA staff, and continues to work with interagency committees on contaminant issues. She previously worked as a senior hydrogeologist within the IRU, and as a hydrogeologist at the Minnesota Pollution Control Agency and an environmental consulting firm. Lisa Yost is a Principal Consultant at ENVIRON, an international consulting firm. She is in their Health Sciences Group, and is based in Saint Paul, Minnesota. Ms. Yost completed her training at the University of Michigan’s School of Public Health and is a board-certified toxicologist with expertise in evaluating human health risks associated with substances in soil, water, and the food chain. She has conducted or supervised risk assessments under CERCLA, RCRA, or state-led regulatory contexts involving a wide range of chemicals and exposure situations. Her areas of specialization include exposure and risk assessment, risk communication, and the toxicology of such chemicals as PCDDs and PCDFs, PCBs, pentachlorophenol (PCP), trichloroethylene (TCE), mercury, and arsenic. Ms. Yost is a recognized expert in risk assessment and has collaborated in original research on exposure issues, including background dietary intake of inorganic arsenic. She is currently assisting in a number of projects, including a complex multi-pathway risk assessment for PDDD/Fs that will integrate extensive biomonitoring data collected by the University of Michigan. Ms. Yost is also an Adjunct Instructor at the University of Minnesota’s School of Public Health. 87 Staff biosketches Wendy Brunner, PhD, serves as surveillance epidemiologist for the MDH Asthma Program since 2002, and joined the MN EPHT program on a part-time basis in fall 2009. Previously, she worked on occupational respiratory disease studies for MDH. She has a masters degree in Science and Technology Studies from Rensselaer Polytechnic Institute and a masters degree in Environmental and Occupational Health from the University of Minnesota. She is currently a doctoral student in the Division of Epidemiology and Community Health at the University of Minnesota. Betsy Edhlund, PhD, is a research scientist in the Environmental Section of the Public Health Laboratory at the Minnesota Department of Health. She works in the metals laboratory developing methods and analyzing samples for both biomonitoring programs and emergency response. Betsy received her PhD in chemistry from the University of Minnesota where her research focused on the photochemistry of natural waters. Jean Johnson, PhD, MS, is Program Director/Principal Investigator for Minnesota’s Environmental Public Health Tracking and Biomonitoring Program. Dr. Johnson received her Ph.D. and M.S. degrees from the University of Minnesota, School of Public Health in Environmental Health and has 25 years of experience working with the state of Minnesota in the environmental health field. As an environmental epidemiologist at MDH, her work has focused on special investigations of population exposure and health, including studies of chronic diseases related to air pollution and asbestos exposure, and exposure to drinking water contaminants. She is currently the Principal Investigator on an EPA grant to develop methods for measuring the public health impacts of population exposure to particulate matter (PM) in air. She is also an adjunct faculty member at the University of Minnesota School of Public Heath. Mary Jeanne Levitt, MBC, is the communications coordinator with the Minnesota Environmental Public Health Tracking program. She has a Masters in Business Communications and has worked for over 20 years in both the public and non-profit sector in project management of research and training grants, communications and marketing strategies, focus groups and evaluations of educational needs of public health professionals. She serves on 3 institutional review boards which specialize in academic research, oncology research, and overall clinical research. Paula Lindgren, MS, received her Master of Science degree in Biostatistics from the University of Minnesota. She works for the Minnesota Department of Health as a biostatistician, and provides statistical and technical support to the MN EPHT and Biomonitoring programs for data reports, publications, web-based portal dissemination and presentations in the Chronic Disease and Environmental Epidemiology section. Ms. Lindgren has also received training in the area of GIS for chronic disease mapping and analysis. In addition to her work for MN EPHT, she works for various programs within Chronic Disease and Environmental Epidemiology including the Asthma program, Center 88 for Occupational Health and Safety, Minnesota Cancer Surveillance System, and Cancer Control section. Barbara Scott Murdock, MA, MPH, is the Program Planner for the Environmental Public Health Tracking and Biomonitoring (EHTB) program, responsible for leading strategic planning and communications with stakeholders and the EHTB Advisory Panel. A biologist and public health professional by education, she has over 30 years of experience in writing and editing professional publications. Recently a grants coordinator/writer for social science faculty at the University of Minnesota, she also served as the biomonitoring project manager at the Minnesota Department of Health (2001-2003); senior research fellow in the Center for Environment & Health Policy, UMN School of Public Health (19952001); director of water and health programs at the Freshwater Foundation (1991-1992); and founding editor of the Health & Environment Digest, a peer-reviewed publication for environmental health and management professionals in the US and Canada (1986-1992). She holds a BS in biochemistry from the University of Chicago, an MA in zoology from Duke University, and an MPH from the University of Minnesota. Jessica Nelson, PhD, is an epidemiologist with the Minnesota Environmental Public Health Tracking and Biomonitoring Program, working primarily on design, coordination, and analysis of biomonitoring projects. Jessica received her PhD and MPH in Environmental Health from the Boston University School of Public Health where her research involved the epidemiologic analysis of biomonitoring data on perfluorochemicals. Jessica was the coordinator of the Boston Consensus Conference on Biomonitoring, a project that gathered input and recommendations on the practice and uses of biomonitoring from a group of Boston-area lay people. Christina Rosebush, MPH, is an epidemiologist with the Minnesota Environmental Public Health Tracking and Biomonitoring Program. Her work includes the development and coordination of biomonitoring projects that assess perfluorochemicals (PFCs) and mercury in Minnesota communities, and collection and statistical analysis of public health surveillance data for EPHT, with a focus on behavioral risk factors. Christina received her Master’s degree in epidemiology from the University of Minnesota’s School of Public Health, completing research in PFC biomonitoring for the Minnesota Department of Health in partial fulfillment of her degree. Jeannette M. Sample, MPH, is an epidemiologist with the Minnesota Environmental Public Health Tracking program at the Minnesota Department of Health, working primarily with the collection and statistical analysis of public health surveillance data for EPHT. She also works on research collaborations with academic partners relating to reproductive outcomes and birth defects. Prior to joining EPHT, she was a CSTE/CDC Applied Epidemiology Fellow with the MDH Birth Defect Information System. Jeannette received her Master’s degree in epidemiology and biostatistics from The George Washington University in Washington, DC. 89 Blair Sevcik, MPH, is an epidemiologist with the Minnesota Environmental Public Health Tracking (EPHT) program at the Minnesota Department of Health, where she works on the collection and statistical analysis of public health surveillance data for EPHT. Prior to joining EPHT in January 2009, she was a student worker with the MDH Asthma Program. She received her Master’s of Public Health degree in epidemiology from University of Minnesota School of Public Health in December 2010. Chuck Stroebel, MSPH, is the MN EPHT Program Manager. He provides day-to-day direction for program activities, including: 1) development and implementation of the state network, 2) development and transport of NCDMs and metadata for the national network, and 3) collaboration and communication with key EPHT partners and stakeholders. Chuck received a Master’s of Public Health in Environmental Health Sciences from the University of North Carolina (Chapel Hill). He has over 15 years of expertise in environmental health, including areas of air quality, pesticides, climate change, risk assessment, and toxicology. Chuck also played a key role in early initiatives to build tracking capacity at the Minnesota Department of Health. Currently, he is a member of the IBIS Steering Committee (state network), the MDH ASTHO Grant Steering Committee (climate change), and the Northland Society of Toxicology. He also serves on the MN EPHT Technical and Communications Teams. Allan N. Williams, MPH, PhD, is an environmental and occupational epidemiologist in the Chronic Disease and Environmental Epidemiology Section at the Minnesota Department of Health. He is the supervisor for the MDH Center for Occupational Health and Safety, which currently includes both the state-funded and federally-funded Environmental Public Health Tracking and Biomonitoring programs. For over 25 years, he has worked on issues relating to environmental and occupational cancer, cancer clusters, work-related respiratory diseases, and the surveillance and prevention of work-related injuries among adolescents. He has served as the PI on two NIOSH R01 grants, as a co-investigator on four other federally-funded studies in environmental or occupational health, and is an adjunct faculty member in the University of Minnesota’s School of Public Health. He received an MA in Biology from Indiana University, an MPH in Environmental Health and Epidemiology from the University of Minnesota, and a PhD in Environmental and Occupational Health from the University of Minnesota 90 Environmental Health Tracking and Biomonitoring Statute $1,000,000 each year is for environmental health tracking and biomonitoring. Of this amount, $900,000 each year is for transfer to the Minnesota Department of Health. The base appropriation for this program for fiscal year 2010 and later is $500,000. 144.995 DEFINITIONS; ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING. (a) For purposes of sections 144.995 to 144.998, the terms in this section have the meanings given. (b) "Advisory panel" means the Environmental Health Tracking and Biomonitoring Advisory Panel established under section 144.998. (c) "Biomonitoring" means the process by which chemicals and their metabolites are identified and measured within a biospecimen. (d) "Biospecimen" means a sample of human fluid, serum, or tissue that is reasonably available as a medium to measure the presence and concentration of chemicals or their metabolites in a human body. (e) "Commissioner" means the commissioner of the Department of Health. (f) "Community" means geographically or nongeographically based populations that may participate in the biomonitoring program. A "nongeographical community" includes, but is not limited to, populations that may share a common chemical exposure through similar occupations, populations experiencing a common health outcome that may be linked to chemical exposures, populations that may experience similar chemical exposures because of comparable consumption, lifestyle, product use, and subpopulations that share ethnicity, age, or gender. (g) "Department" means the Department of Health. (h) "Designated chemicals" means those chemicals that are known to, or strongly suspected of, adversely impacting human health or development, based upon scientific, peerreviewed animal, human, or in vitro studies, and baseline human exposure data, and consists of chemical families or metabolites that are included in the federal Centers for Disease Control and Prevention studies that are known collectively as the National Reports on Human Exposure to Environmental Chemicals Program and any substances specified by the commissioner after receiving recommendations under section 144.998, subdivision 3, clause (6). (i) "Environmental hazard" means a chemical or other substance for which scientific, peerreviewed studies of humans, animals, or cells have demonstrated that the chemical is known or reasonably anticipated to adversely impact human health. (j) "Environmental health tracking" means collection, integration, analysis, and dissemination of data on human exposures to chemicals in the environment and on diseases potentially caused or aggravated by those chemicals. 144.996 ENVIRONMENTAL HEALTH TRACKING; BIOMONITORING. Subdivision 1. Environmental health tracking. In cooperation with the commissioner of the Pollution Control Agency, the commissioner shall establish an environmental health tracking program to: (1) coordinate data collection with the Pollution Control Agency, Department of Agriculture, University of Minnesota, and any other relevant state agency and work to promote the sharing of and access to health and environmental databases to develop an environmental health tracking system for Minnesota, consistent with applicable data practices laws; (2) facilitate the dissemination of aggregate public health tracking data to the public and researchers in accessible format; (3) develop a strategic plan that includes a mission statement, the identification of core priorities for research and epidemiologic surveillance, and the identification of internal and external stakeholders, and a work plan describing future program development and addressing issues having to do with compatibility with the Centers for Disease Control and Prevention's National Environmental Public Health Tracking Program; (4) develop written data sharing agreements as needed with the Pollution Control Agency, Department of Agriculture, and other relevant 91 state agencies and organizations, and develop additional procedures as needed to protect individual privacy; (5) organize, analyze, and interpret available data, in order to: (i) characterize statewide and localized trends and geographic patterns of population-based measures of chronic diseases including, but not limited to, cancer, respiratory diseases, reproductive problems, birth defects, neurologic diseases, and developmental disorders; (ii) characterize statewide and localized trends and geographic patterns in the occurrence of environmental hazards and exposures; (iii) assess the feasibility of integrating disease rate data with indicators of exposure to the selected environmental hazards such as biomonitoring data, and other health and environmental data; (iv) incorporate newly collected and existing health tracking and biomonitoring data into efforts to identify communities with elevated rates of chronic disease, higher likelihood of exposure to environmental hazards, or both; (v) analyze occurrence of environmental hazards, exposures, and diseases with relation to socioeconomic status, race, and ethnicity; (vi) develop and implement targeted plans to conduct more intensive health tracking and biomonitoring among communities; and (vii) work with the Pollution Control Agency, the Department of Agriculture, and other relevant state agency personnel and organizations to develop, implement, and evaluate preventive measures to reduce elevated rates of diseases and exposures identified through activities performed under sections 144.995 to 144.998; and (6) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of environmental health tracking activities and related research programs, with recommendations for a comprehensive environmental public health tracking program. Subd. 2. Biomonitoring. The commissioner shall: (1) conduct biomonitoring of communities on a voluntary basis by collecting and analyzing biospecimens, as appropriate, to assess environmental exposures to designated chemicals; (2) conduct biomonitoring of pregnant women and minors on a voluntary basis, when scientifically appropriate; (3) communicate findings to the public, and plan ensuing stages of biomonitoring and disease tracking work to further develop and refine the integrated analysis; (4) share analytical results with the advisory panel and work with the panel to interpret results, communicate findings to the public, and plan ensuing stages of biomonitoring work; and (5) submit a biennial report to the chairs and ranking members of the committees with jurisdiction over environment and health by January 15, beginning January 15, 2009, on the status of the biomonitoring program and any recommendations for improvement. Subd. 3. Health data. Data collected under the biomonitoring program are health data under section 13.3805. 144.997 BIOMONITORING PILOT PROGRAM. Subdivision 1. Pilot program. With advice from the advisory panel, and after the program guidelines in subdivision 4 are developed, the commissioner shall implement a biomonitoring pilot program. The program shall collect one biospecimen from each of the voluntary participants. The biospecimen selected must be the biospecimen that most accurately represents body concentration of the chemical of interest. Each biospecimen from the voluntary participants must be analyzed for one type or class of related chemicals. The commissioner shall determine the chemical or class of chemicals to which community members were most likely exposed. The program shall collect and assess biospecimens in accordance with the following: (1) 30 voluntary participants from each of three communities that the commissioner identifies as likely to have been exposed to a designated chemical; (2) 100 voluntary participants from each of two communities: (i) that the commissioner identifies as likely to have been exposed to arsenic; and (ii) that the commissioner identifies as likely to have been exposed to mercury; and (3) 100 voluntary participants from each of two communities that the commissioner identifies as likely to have been exposed to perfluorinated chemicals, including 92 perfluorobutanoic acid. Subd. 2. Base program. (a) By January 15, 2008, the commissioner shall submit a report on the results of the biomonitoring pilot program to the chairs and ranking members of the committees with jurisdiction over health and environment. (b) Following the conclusion of the pilot program, the commissioner shall: (1) work with the advisory panel to assess the usefulness of continuing biomonitoring among members of communities assessed during the pilot program and to identify other communities and other designated chemicals to be assessed via biomonitoring; (2) work with the advisory panel to assess the pilot program, including but not limited to the validity and accuracy of the analytical measurements and adequacy of the guidelines and protocols; (3) communicate the results of the pilot program to the public; and (4) after consideration of the findings and recommendations in clauses (1) and (2), and within the appropriations available, develop and implement a base program. Subd. 3. Participation. (a) Participation in the biomonitoring program by providing biospecimens is voluntary and requires written, informed consent. Minors may participate in the program if a written consent is signed by the minor's parent or legal guardian. The written consent must include the information required to be provided under this subdivision to all voluntary participants. (b) All participants shall be evaluated for the presence of the designated chemical of interest as a component of the biomonitoring process. Participants shall be provided with information and fact sheets about the program's activities and its findings. Individual participants shall, if requested, receive their complete results. Any results provided to participants shall be subject to the Department of Health Institutional Review Board protocols and guidelines. When either physiological or chemical data obtained from a participant indicate a significant known health risk, program staff experienced in communicating biomonitoring results shall consult with the individual and recommend follow-up steps, as appropriate. Program administrators shall receive training in administering the program in an ethical, culturally sensitive, participatory, and community-based manner. Subd. 4. Program guidelines. (a) The commissioner, in consultation with the advisory panel, shall develop: (1) protocols or program guidelines that address the science and practice of biomonitoring to be utilized and procedures for changing those protocols to incorporate new and more accurate or efficient technologies as they become available. The commissioner and the advisory panel shall be guided by protocols and guidelines developed by the Centers for Disease Control and Prevention and the National Biomonitoring Program; (2) guidelines for ensuring the privacy of information; informed consent; follow-up counseling and support; and communicating findings to participants, communities, and the general public. The informed consent used for the program must meet the informed consent protocols developed by the National Institutes of Health; (3) educational and outreach materials that are culturally appropriate for dissemination to program participants and communities. Priority shall be given to the development of materials specifically designed to ensure that parents are informed about all of the benefits of breastfeeding so that the program does not result in an unjustified fear of toxins in breast milk, which might inadvertently lead parents to avoid breastfeeding. The materials shall communicate relevant scientific findings; data on the accumulation of pollutants to community health; and the required responses by local, state, and other governmental entities in regulating toxicant exposures; (4) a training program that is culturally sensitive specifically for health care providers, health educators, and other program administrators; (5) a designation process for state and private laboratories that are qualified to analyze biospecimens and report the findings; and (6) a method for informing affected communities and local governments representing those communities concerning biomonitoring activities and for receiving comments from citizens concerning those activities. (b) The commissioner may enter into contractual agreements with health clinics, 93 community-based organizations, or experts in a particular field to perform any of the activities described under this section. 144.998 ENVIRONMENTAL HEALTH TRACKING AND BIOMONITORING ADVISORY PANEL. Subdivision 1. Creation. The commissioner shall establish the Environmental Health Tracking and Biomonitoring Advisory Panel. The commissioner shall appoint, from the panel's membership, a chair. The panel shall meet as often as it deems necessary but, at a minimum, on a quarterly basis. Members of the panel shall serve without compensation but shall be reimbursed for travel and other necessary expenses incurred through performance of their duties. Members appointed by the commissioner are appointed for a three-year term and may be reappointed. Legislative appointees serve at the pleasure of the appointing authority. Subd. 2. Members. (a) The commissioner shall appoint eight members, none of whom may be lobbyists registered under chapter 10A, who have backgrounds or training in designing, implementing, and interpreting health tracking and biomonitoring studies or in related fields of science, including epidemiology, biostatistics, environmental health, laboratory sciences, occupational health, industrial hygiene, toxicology, and public health, including: (1) at least two scientists representative of each of the following: (i) nongovernmental organizations with a focus on environmental health, environmental justice, children's health, or on specific chronic diseases; and (ii) statewide business organizations; and (2) at least one scientist who is a representative of the University of Minnesota. (b) Two citizen panel members meeting the scientific qualifications in paragraph (a) shall be appointed, one by the speaker of the house and one by the senate majority leader. (c) In addition, one representative each shall be appointed by the commissioners of the Pollution Control Agency and the Department of Agriculture, and by the commissioner of health to represent the department's Health Promotion and Chronic Disease Division. Subd. 3. Duties. The advisory panel shall make recommendations to the commissioner and the legislature on: (1) priorities for health tracking; (2) priorities for biomonitoring that are based on sound science and practice, and that will advance the state of public health in Minnesota; (3) specific chronic diseases to study under the environmental health tracking system; (4) specific environmental hazard exposures to study under the environmental health tracking system, with the agreement of at least nine of the advisory panel members; (5) specific communities and geographic areas on which to focus environmental health tracking and biomonitoring efforts; (6) specific chemicals to study under the biomonitoring program, with the agreement of at least nine of the advisory panel members; in making these recommendations, the panel may consider the following criteria: (i) the degree of potential exposure to the public or specific subgroups, including, but not limited to, occupational; (ii) the likelihood of a chemical being a carcinogen or toxicant based on peer-reviewed health data, the chemical structure, or the toxicology of chemically related compounds; (iii) the limits of laboratory detection for the chemical, including the ability to detect the chemical at low enough levels that could be expected in the general population; (iv) exposure or potential exposure to the public or specific subgroups; (v) the known or suspected health effects resulting from the same level of exposure based on peer-reviewed scientific studies; (vi) the need to assess the efficacy of public health actions to reduce exposure to a chemical; (vii) the availability of a biomonitoring analytical method with adequate accuracy, precision, sensitivity, specificity, and speed; (viii) the availability of adequate biospecimen samples; or (ix) other criteria that the panel may agree to; and (7) other aspects of the design, implementation, and evaluation of the environmental health tracking and biomonitoring system, including, but not limited to: (i) identifying possible community partners and sources of additional public or private funding; (ii) developing outreach and educational methods and materials; and 94 (iii) disseminating environmental health tracking and biomonitoring findings to the public. Subd. 4. Liability. No member of the panel shall be held civilly or criminally liable for an act or omission by that person if the act or omission was in good faith and within the scope of the member's responsibilities under sections 144.995 to 144.998. INFORMATION SHARING. On or before August 1, 2007, the commissioner of health, the Pollution Control Agency, and the University of Minnesota are requested to jointly develop and sign a memorandum of understanding declaring their intent to share new and existing environmental hazard, exposure, and health outcome data, within applicable data privacy laws, and to cooperate and communicate effectively to ensure sufficient clarity and understanding of the data by divisions and offices within both departments. The signed memorandum of understanding shall be reported to the chairs and ranking members of the senate and house of representatives committees having jurisdiction over judiciary, environment, and health and human services. Effective date: July 1, 2007 This document contains Minnesota Statutes, sections 144.995 to 144.998, as these sections were adopted in Minnesota Session Laws 2007, chapter 57, article 1, sections 143 to 146. The appropriation related to these statutes is in chapter 57, article 1, section 3, subdivision 4. The paragraph about information sharing is in chapter 57, article 1, section 169. The following is a link to chapter 57: http://ros.leg.mn/bin/getpub.php?type=law&ye ar=2007&sn=0&num=57 Current Appropriation for EHTB (see bolded text on page 96): Office of the Revisor of Statutes 88th Legislature, 2013, Regular Session, Chapter 114 Minnesota Session Laws Subd. 2.Water 25,453,000 25,454,000 Appropriations by Fund General State Government Special Revenue Environmental 3,737,000 3,737,000 75,000 75,000 21,641,000 21,642,000 $1,959,000 the first year and $1,959,000 the second year are for grants to delegated counties to administer the county feedlot program under Minnesota Statutes, section 116.0711, subdivisions 2 and 3. By January 15, 2016, the commissioner shall submit a report detailing the results achieved with this appropriation to the chairs and ranking minority members at the senate and house of representatives committees and divisions with jurisdiction over environment and natural resources policy and finance. Money remaining after the first year is available for the second year. $740,000 the first year and $740,000 the second year are from the environmental fund to address the need for continued increased activity in the areas of new technology review, technical assistance for local governments, and enforcement under Minnesota Statutes, sections 115.55 to 115.58, and to complete the requirements of Laws 2003, chapter 128, article 1, section 165. $400,000 the first year and $400,000 the second year are for the clean water partnership program. Any unexpended balance in the first year does not cancel but is available in the second year. Priority shall be given to projects preventing impairments and degradation of lakes, rivers, streams, and groundwater according to Minnesota 95 Statutes, section 114D.20, subdivision 2, clause (4). $664,000 the first year and $664,000 the second year are from the environmental fund for subsurface sewage treatment system (SSTS) program administration and community technical assistance and education, including grants and technical assistance to communities for water quality protection. Of this amount, $129,000 each year is for assistance to counties through grants for SSTS program administration. A county receiving a grant from this appropriation shall submit the results achieved with the grant to the commissioner as part of its annual SSTS report. Any unexpended balance in the first year does not cancel but is available in the second year.$105,000 the first year and $105,000 the second year are from the environmental fund for registration of wastewater laboratories. $913,000 the first year and $913,000 the second year are from the environmental fund to continue perfluorochemical biomonitoring in eastern metropolitan communities, as recommended by the Environmental Health Tracking and Biomonitoring Advisory Panel, and address other environmental health risks, including air quality. Of this amount, $812,000 the first year and $812,000 the second year are for transfer to the Department of Health. Notwithstanding Minnesota Statutes, section 16A.28, the appropriations encumbered on or before June 30, 2015, as grants or contracts for SSTS's, surface water and groundwater assessments, total maximum daily loads, storm water, and water quality protection in this subdivision are available until June 30, 2018. 96 97
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